- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02001597
Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy (TRUS-RP)
Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications.
The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins.
The investigators objectives are
- To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy
- To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console
This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver General Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- All men who undergo robot-assisted radical prostatectomy are eligible.
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Surgery patients
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates
Tidsram: 1 year
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We will measure and report the time required to carry out the registration of the ultrasound transducer relative to the da Vinci coordinate system for each of the patients.
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1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Successful prostate visualization
Tidsram: 1 year
|
For each patient in the cohort, we will report the total time of ultrasound use and the specific context in which it was used, e.g.
identification of the bladder neck, identification of rectal wall, identification of the seminal vesicles, identification of the prostate apex.
|
1 year
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact on completion time
Tidsram: 1 year
|
We will report the total additional ultrasound set-up time for each of the patients.
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H11-02267
- 385902-2010 (Annat bidrag/finansieringsnummer: CHRP)
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